tbuckley/cabot-search huggingface dataset:
Area deprivation index and breast cancer subtypes in young patients.
Authors: Victoria Chung, Melanie Anne Sheen, Marcia Henry, Susan Olet, Caitlin Taylor, Matthew Alberti, James Peeples, Helen Yuan, Raina Saxena, Rabia Cattie
Journal: Journal of Clinical Oncology (2023)

e18651 Background: Breast cancer (BC) diagnosed under age 40 accounts for approximately 7-9% of all BC diagnoses. Patients diagnosed with BC &lt; age 40 have more aggressive cancers, present at later stages, and poorer outcomes. Socioeconomic status (SES), income, and education have been studied in relation to cancer incidence and prognosis. According to data reviewed from 2008 SEER database, there was no major difference in incidence of female BC among patients of varying poverty levels or annual household income and women with college education had a higher incidence of breast cancer diagnosis compared to those without college education. A composite index of these variables is categorized as Area Deprivation Index (ADI). ADI ranks census bureau neighborhoods by SES and disadvantaged metrics including income, education, employment, and housing. Louisiana and Mississippi have large areas of deprivation in rural and urban areas. Methods: We performed a retrospective chart review and collected data on 746 women diagnosed with BC &lt; age 40 from 2012 to 2022 in single medical system (Ochsner Health System) throughout Louisiana and Mississippi. Data was collected including age at diagnosis, BMI, race, BC subtype, and zip code (to determine ADI). Data was censored for patients without zip codes. We reviewed patients’ BC subtype by ADI to determine if there is a relationship between these young patients’ BC diagnoses and ADI. Cochran-Armitage test was used to determine significance. Results: ADI State Rankings by Quintiles. Conclusions: Young women in regions of lower SES are more likely to be diagnosed with TNBC. As TNBC is an aggressive subtype in a patient population that is predisposed to aggressive BC, this data serves as rationale to increased BC outreach to women in neighborhoods of higher ADI to promote knowledge, risk reduction and early detection. [Table: see text] [Table: see text] [Table: see text]
Retrospective analysis of the effect of COVID-19 in hospitalized cancer patients.
Authors: Senin Shah, Akil Adrian Sherif, Andrew Hsu
Journal: Journal of Clinical Oncology (2023)

e18822 Background: Immunocompromised states such as cancer have been established as predictors of worse outcomes in COVID-19. The pandemic affected delivery of healthcare to this subset of the population, resulting in delays in diagnosis and increasing the overall mortality of cancer patients. We examined outcomes of cancer patients who were hospitalized with COVID-19 across the United States during the COVID-19 pandemic. Methods: We conducted a retrospective analysis of the discharge data from National Inpatient Sample (NIS), from 2020. A search was performed using ICD-10 codes for cancer (solid, hematologic and metastatic) and COVID-19. Patients with a primary diagnosis of COVID-19 and secondary diagnosis of cancer were identified. Baseline characteristics were analyzed. Outcomes of in-hospital mortality, length of stay (LOS) and health care costs were compared between patients with cancer and COVID-19, and those with cancer without COVID-19. Multivariate regression analysis was used to adjust for confounders. Results: We identified a total of 1,759,235 hospitalizations related to cancer out of which 45,660(2.6%) also had COVID-19. Cancer patients with COVID-19 were more likely to be older (69.8 vs 65.6 years, P &lt; 0.001), African-American (18.2 vs 13.33 %, P &lt; 0.001), Hispanic (14.3 vs 8.8 %, p = 0.002), and had a median household income in the 1st quartile (30.6 vs 26.2%, p &lt; 0.001). Cancer patients with COVID-19 were also more likely to have diabetes, hypertension, obesity, CKD, chronic pulmonary disease, and heart failure (p-values &lt; 0.001). Multivariate logistic regression analysis of the two groups showed that cancer patients with COVID-19 had higher odds of dying in the hospital (19.2% vs 6.6%) with adjusted odds ratio (aOR) 3.13 (P &lt; 0.001, CI: 2.95-3.31). Cancer patients with COVID-19 also had statistically significant higher LOS (8.6 vs 6.1 days; aOR 2.49; P &lt; 0.001 and CI: 2.12-2.56) and higher rates of mechanical ventilation (10.8 vs 4.4%; aOR 2.49; P &lt; 0.001; CI:2.33-2.66). Mean hospitalization charges were higher in cancer patients with COVD-19 ($101,538 vs $85,756; P &lt; 0.001). Conclusions: In patients hospitalized with cancer, those with COVID-19 had higher odds of in hospital mortality as compared to those without COVID-19. Patients with cancer and COVID-19 were more likely to be older, African American and had a higher comorbidity burden. This data is consistent with previous studies that have established that COVID-19 disproportionally affected people of lower socio-economic status, African Americans and Hispanics. It is noteworthy that these differences persist in the cancer population, even though they are presumably more active participants in healthcare, highlighting the racial and socio-economic disparities in our healthcare system. This study re-enforces the importance of preventative public health measures and investigating the social determinants of health in this high-risk population.
Clinical characteristics, survival outcomes, and prognostic factors in subcutaneous panniculitis like T-cell lymphoma: National Cancer Database analysis (2004-2018).
Authors: Firas Baidoun, Jason Sluzevich, Han W. Tun, Muhamad Alhaj Moustafa
Journal: Journal of Clinical Oncology (2023)

e19548 Background: Subcutaneous panniculitis-like T-cell lymphoma (SPTCL) is a rare lymphoma accounting for less than 1% of mature T-cell lymphomas. Its natural history is not understood due to lack of large studies with long-term followup and an optimal therapeutic approach is not well-defined. Methods: The National Cancer Database was queried for patients aged 18 years and older diagnosed with SPTCL between 2004 and 2018. We excluded patients who lost to follow-up. Kaplan-Meier and multivariate Cox regression were used in the analyses. Results: 353 patients with SPTCL were included. 63% were females, 62% Caucasian, and 26% African American, 50% had early stage (I and II) and 32% had advanced stage (III and IV). 58.4% received chemotherapy, 38.2% did not receive chemotherapy and 3.4% had unknown chemotherapy status. The median age at diagnosis was 49 years (range 18-90). The median overall survival (mOS) for the whole cohort was not reached In early-stage (N = 178), 49.5% had chemotherapy with 39% receiving single-agent chemotherapy and 60% receiving multi-agent chemotherapy. 18.5% received radiation. In advanced-stage (N = 112), 75.9% received chemotherapy with 19% receiving single-agent chemotherapy and 81% receiving multi-agent chemotherapy. 9.8% received radiation There was no significant difference in the mOS between advanced-stage and early-stage (161.5 months vs not reached, P = 0.051) In early stage, there was no significant difference in the OS between chemotherapy and no chemotherapy (mOS was not reached in both groups, P = 0.324). The same trend was seen in the advanced stage (mOS was not reached in both groups, P = 0.851) Compared to Caucasian, African American patients were younger (median age 47 vs 54 years), but there was no significant difference in disease stage, receiving chemotherapy or radiation or other disease related characteristics (IPI score, B-symptoms, and HIV infection). African American patients had better OS (mOS was not reached, P = 0.003). This significant difference was seen in early stage (mOS was not reached, P = 0.003), but not in advanced stage (mOS 162 vs 122 months, P = 0.113) On multivariate analysis, age and Charlson-Deyo score ≥3 were associated with worse OS (HR 1.028 95% CI 1.005-1.052; P = 0.018 and HR 14.711 95% CI 2.316-93.449; P = 0.004, respectively), whereas disease stage and chemotherapy status did not affect the OS (HR 0.938 95% CI 0.545-1.617; P = 0.819, HR 1.271 95% CI 0.175-9.255; P = 0.813, and HR 0.922 95% CI 0.489-1.738; P = 0.802, respectively). Conclusions: Our study indicates that SPTCL is predominantly an indolent lymphoma associated with long-term survival irrespective of stage and chemotherapy. A conservative therapeutic approach appears to be more appropriate than intensive therapeutic approach in most patients. A risk stratification algorithm is needed to determine the therapeutic intensity.
Phase 3 RCT of dexamethasone versus placebo for chemotherapy induced fatigue in patients with advanced solid malignancies.
Authors: Venkatraman Radhakrishnan, Vidhya Gopalakrishnan, Vamsi Vihari, Venkata Siva Kiran Kumar Dasapathi, Swaminathan Rajaraman, Jayachandran Perumal Kalaiyarasi, Priya Iyer, Arvind Krishnamurthy, Sridevi V, Surendran Veeraiah
Journal: Journal of Clinical Oncology (2023)

12112 Background: Short-term steroids (&lt;2 weeks) have been used to alleviate fatigue in patients with advanced cancer. However, the efficacy and safety of long-term steroids (12 weeks) in patients with advanced cancer receiving palliative chemotherapy have not been studied. Methods: The study was an open-label, placebo-controlled, phase 3 RCT to evaluate the efficacy and safety of low dose dexamethasone (DEX) in reducing chemotherapy and cancer associated fatigue. Patients aged 18-60 years with performance status ≤2, undergoing palliative chemotherapy for advanced solid malignancies were randomized 1:1 to receive either DEX (4mg/day) or a placebo for 12 weeks. Fatigue was measured using the Symbolic Assessment of Fatigue Extent (SAFE) scale and EORTC FA12 scale, and quality of life (QOL) was assessed using the EORTC QLQ c30 at baseline, 6 weeks, and 12 weeks. The primary endpoint was to compare fatigue between the study arms at 6 weeks. Secondary endpoints were to compare fatigue at 12 weeks, QOL and toxicities. With a power of 80%, α of 5% (2-sided), 126 patients (including 25% drop-outs) were required to show the superiority of DEX in reducing SAFE fatigue extent score by 50% at 6 weeks. Results: A total of 126 patients were randomized (64 in the placebo arm and 62 in the DEX arm) between Oct 2018-Sep 2022. The median age was 46.5 years and 67% were females. Metastatic breast (28%) and lung (16%) cancer were the common diagnosis. Twelve and 23 patients in the placebo arm and 13 and 22 patients in the DEX arm did not undergo week 6 and 12 assessment respectively due to disease progression. The results showed no significant differences in mean SAFE scores, FA12 scores, or QOL between the study arms at 6 and 12 weeks, except for higher FA12 social sequelae in the DEX arm at 12 weeks (P=0.048) (Table). There were no significant differences in toxicities between the arms. Conclusions: The results of this study suggest that low-dose DEX is not effective in reducing chemotherapy associated fatigue or improving QOL in patients with advanced cancer. Clinical trial information: CTRI/2018/08/015222 . [Table: see text]
A phase 3, open-label, randomized study to evaluate the efficacy and safety of single-agent belantamab mafodotin (belamaf) compared to pomalidomide plus low-dose dexamethasone (Pd) in patients (pts) with relapsed/refractory multiple myeloma (RRMM): DREAMM-3.
Authors: Katja Weisel, Vania TM Hungria, Atanas Radinoff, Sosana Delimpasi, Gabor Mikala, Tamas Masszi, Jian Li, Marcelo Capra, Morio Matsumoto, Neal Sule, Mary Li, Astrid McKeown, Wei He, Shelley Bright, Brooke Currie, Julia Boyle, Joanna Opalinska, Meletios A. Dimopoulos
Journal: Journal of Clinical Oncology (2023)

8007 Background: Belamaf, an antibody-drug conjugate targeting B-cell maturation antigen, induces cell death by direct cell kill and immune-mediated mechanisms. The DREAMM-2 trial (NCT03525678) showed rapid, deep and durable responses to belamaf monotherapy in pts with RRMM. The Phase 3, open-label, randomized, multicenter DREAMM-3 trial (NCT04162210) evaluated belamaf monotherapy vs Pd in adult pts with RRMM at second relapse (third line) or later. Methods: Pts were randomized (2:1) to belamaf 2.5 mg/kg Q3W or Pd (pom 4 mg PO daily on days 1–21 of 28 day cycle; dex, 40mg PO [20mg if &gt;75 years]) Q1W. The primary endpoint was progression free survival (PFS). Results: 325 pts were enrolled (belamaf n=218, Pd n=107). Median (range) age was 68 (38–90) years; 57% were male. Median (range) duration of exposure for belamaf was 4.1 (0.4, 22.9) months (mo) and 5.3 (0.4, 24.0) for Pd. Median (range) duration of follow-up was 11.5 (0.6, 24.2) mo for belamaf and 10.8 (0.0, 26.4) mo for Pd. Median PFS was longer for belamaf (11.2 [6.4, 14.5] mo) vs. Pd (7.0 [4.6, 10.6] mo). There was no statistically significant difference in PFS between the 2 treatment groups, (HR 1.03 [95% CI: 0.72, 1.47]), based on the stratified Cox model (p=0.558). Belamaf induced deeper responses vs Pd (Table). Median duration of response (DoR) was more durable for belamaf than for Pd (Table). At 12 mo, the probability (95% CI) of maintaining response was 0.768 (0.641, 0.854) for belamaf and 0.484 (0.258, 0.679) for Pd. Median PFS2 was 18.7 mo (95% CI 14.5, NR) for belamaf and 12.7 mo (9.3, 21.1) for Pd. PFS2 rate at 6 mo was 73% for belamaf and 76% for Pd. Overall survival (OS) data were immature (37.5% overall maturity) at this analysis; median OS was 21.2 mo (95% CI 18.7, NR) for belamaf and 21.1 mo (15.1, NR) for Pd (HR 1.14 [95% CI 0.77, 1.68]; p=0.746). Adverse events (AEs) were reported in 97% and 93% of patients (Table). The safety profile was consistent with previous reports for belamaf and Pd. Conclusions: Belamaf monotherapy did not demonstrate PFS superiority when compared to a doublet (Pd). However, median PFS was longer for belamaf monotherapy and belamaf induced deeper, more durable responses than Pd. No new safety signals were observed. Subgroup analyses and PRO outcomes will be reported. Belamaf continues to be investigated in combination with established and novel agents.[Table: see text]
Interim analysis of MelaRisk, a biomarker assay validation study in stage IB/IIA melanoma tissue.
Authors: Stephan Forchhammer, Eftychia Chatziioannou, Tobias Sinnberg, Heike Niessner, Ulrike M. Leiter, Ulrike Keim, Andrea Forschner, Claus Garbe, Lukas Flatz, Teresa Maria Santos Amaral
Journal: Journal of Clinical Oncology (2023)

e21591 Background: Adjuvant therapy for melanoma patients (pts) is now available for pts from stage IIB onwards. Pts with cutaneous melanoma in early stages stage IB/IIA have low risk of relapse. However, this group still contributes to the most melanoma deaths in absolute numbers. Therefore, it is important to identify pts in stage IB/IIA that could benefit from adjuvant therapy. One promising biomarker is a proprietary 7-protein immunohistochemistry (7-P-IHC) signature (Immunoprint). Based on primary tumor tissue analysis, the 7-P-IHC has shown very high sensitivity and risk enhancement ability in previous prospective and retrospective validations. 1,2 The 7-P-IHC test result indicates a risk score predicting relapse-free and melanoma-free survival (RFS, MSS), thereby allocating most relapses to the high score risk group. To further validate its key parameters, the MelaRisk trial was started in 2022, aiming to analyze up to 500 tissue samples with Immunoprint. Here we present its interim analysis and a combined analysis of all available data for Immunoprint in stage IB/IIA. Methods: All pts with available formalin-fixed paraffin-embedded blocks of the Central German Melanoma Registry diagnosed from 2005-16 and AJCC v8 stage IB/IIA were screened. Tumor tissue samples from 119 pts (83/IB; 36/IIA) were available; the 7-P-IHC was used to determine a risk group. Results: 7-P-IHC assigned 68 pts to the low-risk (57%) and 51 (43%) to the high-risk group. Median follow-up was 76 months. 15/17 relapses after 5-years were detected, resulting in a sensitivity of 88%. 5-years RFS event rate of the cohort according to AJCC v8 was 12% and 19% for stages IB and IIA, respectively. This was enhanced to a risk of recurrence of 30% (stage IB) and 29% (stage IIA) in the respective high score group. 5y-RFS rate was 97% for pts with 7-P-IHC low score risk and 71% for pts with 7-P-IHC high score risk (p=0.0001). 7-P-IHC was the only significant factor in a multivariate Cox analysis for RFS (HR 10.78 (2.38-48.74), p=0.002) and could detect 4/5 MSS events. Combined analysis including these and previous Immunoprint results in stage IB/IIA are summarized in the table. Conclusions: 7-P-IHC could concentrate 88% of stage IB/IIA RFS events in a small high score risk group. This group entails 43% of pts of the total cohort, correctly identifying pts needing adjuvant therapy. Immunoprint should be used to select pts in future studies in the adjuvant setting if these promising interim results can be confirmed in the final analysis. 1. Meyer et al. (2023) EJC; 2. Reschke et al. (2021). [Table: see text]
Real-world data on incidence of acute adverse reactions (AARs) reported in clinical practice.
Authors: Laura A. Ferrari, Katia F. Dotti, Gabriella Mariani, Valentino I. Redaelli, Barbara Re, Erika Cataldo, Filippo G. De Braud
Journal: Journal of Clinical Oncology (2023)

e18814 Background: AARs are a significant concern in cancer treatment practice. The exact mechanisms underlying AARs are not fully understood. Their occurrence, even if rare, is unpredictable.This study updates the incidence of AARs in our large cohort of administrations as well as the impact on AARs of the increased number of targeted therapy drugs entered the clinical routine.Several new oncologic drugs have been rapidly developed in the last decade and many of them approved through a fast-track process.Medical Day Hospital of the Fondazione IRCCS Istituto Nazionale dei Tumori provides parenteral treatments for adult oncologic and hematological outpatients of the Medical Oncology Department, with a yearly average of 20,000 treatments, 25% of which are represented by investigational new drugs. Methods: A retrospective analysis of the AARs occurred between January 2020 and December 2022 was conducted.Overall, 61,096 treatments were performed. Therapeutic schemes included chemotherapies, targeted therapies, or both.Excluding the 14,667 investigational treatments, we analyzed 46,429 therapeutic regimens recorded in our database corresponding to 55,895 preparations of non-investigational drugs. Sixty % (33,580) of these preparations were chemotherapies and 40 % targeted therapies (22,315).All patients receiving chemotherapies were premedicated with steroids, while targeted therapies premedication was not always used.As part of the pharmacovigilance program, AARs occurring during injections of approved drugs were registered and reported to AIFA and Eudravigilance.It’s noteworthy that Covid-19 emergency interfered only marginally ( &lt; 10 %) with the amount of administrations performed during that period. Results: A total of 496 AARs out of 55,895 administrations were registered (0,9 %), of which 358 (72 %) were reported with chemotherapies and 138 (28 %) with targeted therapies.The great majority of AARs reported was not severe. Fourteen reactions ( 3% ) were classified as severe, six of them in the targeted therapy group.In order of frequency, among chemotherapies, reactions were more often associated with oxaliplatin, liposomal doxorubicin, etoposide, paclitaxel, vinflunin, docetaxel, cabazitaxel, fludarabine, cisplatin (relative incidence ≥ 1,5 %), while among targeted therapies with rituximab and isatuximab (2,5 % respectively) and TDM1, panitumumab, daratumumab, durvalumab (≥ 0,5 %). Conclusions: This single institutional study suggests useful informations to support safe management of current oncological treatments.Compared to published data, our findings show a low incidence of AARs.Better recognition of potential risk factors and recommendations about premedications, infusions rate and infusion reactions’ management could improve treatment outcome and healthcare drug delivery-related cost.
Therapeutic effects of combination with EGFR-TKIs and radiotherapy on the prognosis of stage IV lung adenocarcinomas harboring 19-Del or 21-L858R: A retrospective study.
Authors: Shuai Liang, Chengming Li, Yingyun Zhang, Dong Hua
Journal: Journal of Clinical Oncology (2023)

e21067 Background: To evaluate the therapeutic effects of combining epidermal growth factor receptor-tyrosine kinase inhibitors (EGFR-TKIs) with radiotherapy on the prognosis of patients with stage IV lung adenocarcinomas (LUAD) that harbor either exon 19 deletion (19-Del) or exon 21 L858R mutation (21-L858R). Methods: Clinical data in the real-world study were retrospectively collected and analyzed from 177 stage IV LUAD patients who received the combination of EGFR-TKIs and radiotherapy at Shandong Cancer Hospital between June 2012 and August 2017. And the primary endpoint of the study was overall survival (OS). Results: The results revealed that the stage IV LUAD patients harboring 19-Del showed similar clinical characteristics as those harboring 21-L858R (all P &gt; 0.05). The median OS (mOS) of all patients was 32.0 (95%CI, 28.6-35.5) months. Multivariate analysis identified EFGR mutations and thoracic radiotherapy as the independent factors in predicting OS ( P = 0.001, 0.013, respectively). Moreover, subgroup analysis showed that patients who received EGFR-TKIs plus bone metastasis radiotherapy or thoracic radiotherapy showed a longer OS in 19-Del group than those in 21-L858R group (mOS, 34.7 vs. 25.1 months, 51.0 vs. 29.6 months; P = 0.0056, 0.0013, respectively), while not observed for patients with brain metastasis radiotherapy (mOS, 34.7 vs. 25.1 months; P = 0.088). Conclusions: Although there were no significant differences in clinical characteristics of stage IV LUAD patients between 19-Del group and 21-L858R group, patients harboring 19-Del could still achieve longer OS than those harboring 21-L858R after receiving EGFR-TKIs in combination with radiotherapy.